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Strength Training and Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00629005
First received: February 19, 2008
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

People with stroke experience weakness and incoordination. Studies have shown that with functional task practice, people can increase motor control and strength to a certain extent. This study will investigate whether adding progressive resistance strength training to functional task practice modeled after Constraint-Induced Movement Therapy results in greater motor function gains than functional task practice alone


Condition Intervention Phase
Stroke
 Behavioral: Constraint-Induced Movement Therapy + strength training
Behavioral: Constraint-Induced Movement Therapy + range of motion
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Should We Train Strength or Skill in Post-Stroke Rehabilitation?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Fugl-Meyer Motor Assessment - UE Subscale [ Time Frame: Immediately after the end of therapy and 6 months later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wolf Motor Function Test [ Time Frame: Immediately after the end of therapy and 6 months later ] [ Designated as safety issue: No ]
  • Cortical mapping using transcranial magnetic stimulation [ Time Frame: Immediately after the end of therapy ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2008
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Constraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus 1 hour of strength training for the arms and hands 3x/week
 Behavioral: Constraint-Induced Movement Therapy + strength training
Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of resistance elastic band exercises
Other Name: forced use, functional task practice, progressive resistive exercise
Active Comparator: Arm 2
Constraint-Induced Movement Therapy (wear a mitt on non-paretic hand for 90% of waking hours + functional task practice for 3 hours) plus non-resisted arm and hand movements for 1 hour 3x/week
 Behavioral: Constraint-Induced Movement Therapy + range of motion
Participants wears a mitt on non-paretic hand for 90% of waking hours and completes 3 hours of functional task practice (e.g., flipping cards, putting coins in coin slot, putting cans on a shelf) plus 1 hour of unresisted arm movements for
Other Name: forced use, functional task practice

Detailed Description:

To date most investigations of UE rehabilitation have examined single interventions. However, combining 2 efficacious interventions may enhance effectiveness. Both functional task training and strength training are beneficial for promoting improved upper extremity function, but they have seldom been studied as a coupled therapy. The research proposed in this project will examine the effect on UE function of adding UE resistive exercises to functional task training. Secondary aims are to examine the effect of stroke severity on the response to therapy, the interrelationship between therapy-induced neural changes and movement composition and functional changes with therapy, and test for retention of UE function gains over 6 months. Individuals with chronic hemiparesis from stroke will complete baseline testing and then be randomly assigned to either the functional task + strength training group or the functional task training alone group. Each group will train 4 hours/day, 3 days/week for 4 weeks. Each will perform 3 hours of functional task training per session. The strengthening group will then complete 1 hour of UE progressive resistance exercises while the functional task training alone group will complete gravity eliminated range of motion exercises for 1 hour. All subjects will be post-tested and then complete follow-up testing 6 months later.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 40-85;
  2. a single unilateral middle cerebral artery ischemic stroke;
  3. no history of drug/alcohol abuse;
  4. ability to follow 3-step commands and provide informed consent;
  5. no history of other neural disorder/dysfunction (including epilepsy), no serious medical illness or refractory depression;
  6. at least 300 active upper extremity elevation in scapular plane (combination of flexion and abduction);
  7. ability to extend the wrist 20 degrees, and two fingers and thumb 10 degrees three times in a minute;
  8. permission of physician (BRRC medical director or BRRC neurologist) to participate in strength training.

Exclusion Criteria:

  1. spasticity in elbow or hand (Modified Ashworth Scale > 2);
  2. Motor Activity Log32 scores >3 (which would indicate relatively good use of the upper extremity);
  3. ability to complete 135 degrees shoulder elevation easily with elbow straight (e.g., doesn't hold breath, movement is fluid, little to no effort tremor observed);
  4. ataxia, major sensory deficits, or hemi-inattention/neglect;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629005

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Stephen E. Nadeau, MD BS BS North Florida/South Georgia Veterans Health System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00629005     History of Changes
Other Study ID Numbers: B5033-W
Study First Received: February 19, 2008
Last Updated: January 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
rehabilitation
upper extremity
motor skills

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on June 13, 2013